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Neisseria gonorrhoeae

Clinical Specimen Submission Guidance

Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM

Lab

STI & Arbovirus Laboratory 401-222-5591

Analyte Name

Neisseria gonorrhoeae

Disease

Gonoccal Infection (Gonoccal infection)

Test Description

Chlamydia trachomatis (CT) / Neisseria gonorrhoeae (NG) testing is performed using the FDA-cleared Aptima Combo 2 Assay for CT/NG (Hologic) on the Panther System.

FDA cleared specimens include: male and female urine specimens, Clinician-collected swabs (endocervical, vaginal, male urethral, pharyngeal, rectal) and patient-collected vaginal swabs.

Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis.

Special Instructions

Specimen Collection: (Follow instructions for collection printed on each collection kit) This test is only approved for specimen types listed in Specimen Section. Specimens received from other sites will be rejected.

NOTE: The performance of the Aptima Combo 2 Assay has not been evaluated in adolescents less than 14 years of age.

Specimen

NOTE: SPECIMENS RECEIVED FROM ADOLESCENTS LESS THAN 14 YEARS OF AGE WILL NOT BE TESTED BY RISHL.

Aptima Unisex Swab Collection Kit: (Clinician- collected) endocervical and male urethral.

Aptima Multitest Swab Collection Kit: (Clinician or patient collected) vaginal, pharyngeal, and rectal.

Note: if requested, a single Clinician-collected Unisex Swab Collection Kit (endocervical) or Clinician-collected Multitest Swab Collection Kit (vaginal) can be used for testing Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Aptima Urine Collection Kit: male and female urine specimens.

Note: if requested, a single Urine Collection Kit can be used for testing Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

For additional information refer to the specimen collection tube guidance chart 

Hold specimen at 2° - 30°C until transport.

Specimen Identification

CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Chlamydia / Gonorrhea

Indicate source type in Source/Site box on requisition

Transport

Swab specimen must be received within 60 days of collection.

Urine specimen must be received with in 30 days of collection.

Refrigerated: Transport and deliver to the laboratory within 24 hours of collection at 2-8°C in a cooler able to maintain specimen temperature. A plug-in electric cooler is recommended, however, a cooler packed with excess frozen gel packs is acceptable as long as the transport temperature is maintained at 2-8°C. 

Specimens must be packaged & transported in accordance with current federal shipping regulations.

Integrity

Specimens not received in approved collection kit will be rejected.

Normal Value

Negative

Reporting Requirement

Providers must report patient information on Gonoccal Infection within 4 days using the RIDOH reportable disease form.

Turnaround Time

3 Business Days

Kit

Kits are available from the RISHL Center for Laboratory Support Services and may be obtained Monday-Friday between 8:30 am and 4:30 pm. Kit order forms can be emailed to ridoh.centralservices@health.ri.gov